MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTERVASCULAR CATHETER

Catalog Number 381534

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter had a needle that broke off during use.No report of serious injury or medical intervention.

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter had a needle that broke off during use.No report of serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: received one used iag 20ga unit and paper top web label from the lot number 8005758.The unit was received in a plastic container broken up.Dhr review was performed on the lot number 8005857.The lot number was built on afa line 6, from january 8, 2018 thru january 12, 2018.Review of the dhr revealed all required challenges samples, set-up and in-process testing was performed per specification in accordance with the quality sampling plans.Setup and in process samples for needle retraction by button activation were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Visual/microscopic evaluation: the wedge/catheter tubing was removed from the adapter and on the needle.The needle/hub was removed from the grip.The needle was curved.The spring was loose and stretched out.The grip and the safety barrel were separated at the area of connection.The ends of both pieces had stress marks and were smashed.Conclusion(s): based on the received condition of the returned unit; the defects needle broken, and needle retraction failure could not be confirmed or replicated with the condition of the returned unit.There was extensive damage to the product.Patient residue observed within the unit indicates the needle and catheter were correctly assembled at the time of use.The extent of damage to the tubing and the cannula exhibited with the returned unit would have been observed during the insertion process by the clinician; therefore, the damage happened after use.There was no definite physical or mechanical evidence that confirmed and supported manufacturing process related issues for the defect observed in this incident.Customer complaint trends are evaluated monthly.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted field: device returned to manufacture: yes.

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter had a needle that broke off during use.No report of serious injury or medical intervention.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7652915
• MDR Text Key: 113004319
• Report Number: 1710034-2018-00374
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903815340
• UDI-Public: 00382903815340
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 381534
• Device Lot Number: 8005857
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other